[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Pages 37772-37776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15549]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-393]
Proposed Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
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SUMMARY: The Drug Enforcement Administration proposes to establish the
2015 aggregate production quotas for controlled substances in schedules
I and II of the Controlled Substances Act and assessment of annual
needs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before August 1, 2014. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after
midnight Eastern Time on the last day of the comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-393'' on all electronic and written correspondence.
The DEA encourages that all comments be submitted electronically
through the Federal eRulemaking Portal which provides the ability to
type short comments directly into the comment field on the Web page or
attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for
submitting comments. Paper comments that duplicate electronic
submissions are not necessary. Should you, however, wish to submit
written comments, in lieu of electronic comments, they should be sent
via regular or express mail to: Drug Enforcement Administration,
Attention: DEA Federal Register Representative/ODW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Erika Gehrmann, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record and will be made available for
public inspection online at http://www.regulations.gov. Such
information includes personal identifying information (such as your
name, address, etc.) voluntarily submitted by the commenter.
The Freedom of Information Act (FOIA) applies to all comments
received. If you want to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
it to be made publicly available, you must include the phrase
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
comment. You must also place all the personal identifying information
you do not want made publicly available in the first paragraph of your
comment and identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment. If
a comment has so much confidential business information that it cannot
be effectively redacted, all or part of that comment may not be made
publicly available. Comments containing personal identifying
information or confidential business information identified as directed
above will be made publicly available in redacted form.
An electronic copy of this document is available at http://www.regulations.gov for easy reference. If you wish to personally
inspect the comments and materials received or the supporting
documentation the DEA used in preparing the proposed action, these
materials will be available for public inspection by appointment. To
arrange a viewing, please see the FOR FURTHER INFORMATION CONTACT
paragraph above.
Legal Authority
Section 306 of the Controlled Substances Act (CSA), 21 U.S.C. 826,
requires the Attorney General to determine the total quantity and
establish aggregate production quotas for each basic class of
controlled substance listed in schedules I and II and for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. This
responsibility has been delegated to the Administrator of the DEA
pursuant to 28 CFR 0.100(b). The Administrator, in turn, has
redelegated that authority to the Deputy Administrator, pursuant to 28
CFR part 0 subpart R, App.
Analysis for Proposed 2015 Aggregate Production Quotas and Assessment
of Annual Needs
The proposed year 2015 aggregate production quotas and assessment
of annual needs represent those quantities of schedule I and II
controlled substances, and the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, to be manufactured in the
United States in 2015 to provide for the estimated medical, scientific,
research, and industrial needs of the United States, lawful export
requirements, and the establishment and maintenance of reserve stocks.
These quotas include
[[Page 37773]]
imports of ephedrine, pseudoephedrine, and phenylpropanolamine but do
not include imports of controlled substances necessary to provide for
the medical, scientific, or other legitimate needs of the United
States.
In determining the proposed 2015 aggregate production quotas and
assessment of annual needs, the DEA has taken into account the criteria
that the DEA is required to consider in accordance with 21 U.S.C.
826(a), 21 CFR 1303.11 (aggregate production quotas for controlled
substances), and 21 CFR 1315.11 (assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA proposes
the aggregate production quotas and assessment of annual needs for 2015
by considering: (1) Total net disposal of the class or chemical by all
manufacturers and chemical importers during the current and two
preceding years; (2) trends in the national rate of net disposal of the
class or chemical; (3) total actual (or estimated) inventories of the
class or chemical and of all substances manufactured from the class or
chemical, and trends in inventory accumulation; (4) projected demand
for such class or chemical as indicated by procurement and chemical
import quotas requested in accordance with 21 CFR 1303.12, 1315.32, and
1315.34; and (5) other factors affecting the medical, scientific,
research, and industrial needs in the United States, lawful export
requirements, and reserve stocks, as the Deputy Administrator finds
relevant. Other factors the DEA considered in calculating the aggregate
production quotas, but not the assessment of annual needs, include
product development requirements of both bulk and finished dosage form
manufacturers, and other pertinent information. In determining the
proposed 2015 assessment of annual needs, the DEA used the calculation
methodology previously described in the 2010 and 2011 assessment of
annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20,
2010, respectively).
The DEA also specifically considered that inventory allowances
granted to individual manufacturers may not always result in the
availability of sufficient quantities to maintain an adequate reserve
stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24.
This would be concerning if a natural disaster or other unforeseen
event resulted in substantial disruption to the amount of controlled
substances available to provide for legitimate public need. As such,
the DEA proposes to include in all schedule II aggregate production
quotas, and certain schedule I aggregate production quotas (gamma-
hydroxybutyric acid and tetrahydrocannabinols), an additional 25% of
the estimated medical, scientific, and research needs as part of the
amount necessary to ensure the establishment and maintenance of reserve
stocks. The resulting established aggregate production quotas will
reflect these included amounts. This action will not affect the ability
of manufacturers to maintain inventory allowances as specified by
regulation. The DEA expects that maintaining this reserve in certain
established aggregate production quotas will mitigate adverse public
effects if an unforeseen event resulted in substantial disruption to
the amount of controlled substances available to provide for legitimate
public need, as determined by the DEA. The DEA does not anticipate
utilizing the reserve in the absence of these circumstances.
The Deputy Administrator, therefore, proposes to establish the 2015
aggregate production quotas for the following schedule I and II
controlled substances and assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Proposed
established
Basic class 2015 quotas
(g)
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3- 15
tetramethylcyclopropyl)methanone (UR-144)..............
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- 15
tetramethylcyclopropyl)methanone (XLR11)...............
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one 15
(butylone).............................................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one 15
(pentylone)............................................
1-(1-Phenylcyclohexyl)pyrrolidine....................... 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....... 45
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...... 45
1-[1-(2-Thienyl)cyclohexyl]piperidine................... 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45
200)...................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)................. 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 45
and RCS-8).............................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)................. 45
1-Methyl-4-phenyl-4-propionoxypiperidine................ 2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)...... 45
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....... 45
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...... 45
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....... 45
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....... 45
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)... 45
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..... 45
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..... 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........ 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................ 30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 15
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....... 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 15
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 15
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)...............................................
2-(Methylamino)-1-phenylpentan-1-one (pentedrone)....... 15
[[Page 37774]]
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 25
2,5-Dimethoxy-4-n-propylthiophenethylamine.............. 25
2,5-Dimethoxyamphetamine................................ 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)...................................................
3,4,5-Trimethoxyamphetamine............................. 25
3,4-Methylenedioxyamphetamine (MDA)..................... 55
3,4-Methylenedioxymethamphetamine (MDMA)................ 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 40
3,4-Methylenedioxy-N-methylcathinone (methylone)........ 50
3,4-Methylenedioxypyrovalerone (MDPV)................... 35
3-Fluoro-N-methylcathinone (3-FMC)...................... 15
3-Methylfentanyl........................................ 2
3-Methylthiofentanyl.................................... 2
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 25
4-Fluoro-N-methylcathinone (4-FMC)...................... 15
4-Methoxyamphetamine.................................... 100
4-Methyl-2,5-dimethoxyamphetamine (DOM)................. 25
4-Methylaminorex........................................ 25
4-Methyl-N-ethylcathinone (4-MEC)....................... 15
4-Methyl-N-methylcathinone (mephedrone)................. 45
4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP)....... 15
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 68
phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5-Methoxy-3,4-methylenedioxyamphetamine................. 25
5-Methoxy-N,N-diisopropyltryptamine..................... 25
5-Methoxy-N,N-dimethyltryptamine........................ 25
Acetyl-alpha-methylfentanyl............................. 2
Acetyldihydrocodeine.................................... 2
Acetylmethadol.......................................... 2
Allylprodine............................................ 2
Alphacetylmethadol...................................... 2
alpha-Ethyltryptamine................................... 25
Alphameprodine.......................................... 2
Alphamethadol........................................... 2
alpha-Methylfentanyl.................................... 2
alpha-Methylthiofentanyl................................ 2
alpha-Methyltryptamine (AMT)............................ 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............. 15
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............ 15
Aminorex................................................ 25
Benzylmorphine.......................................... 2
Betacetylmethadol....................................... 2
beta-Hydroxy-3-methylfentanyl........................... 2
beta-Hydroxyfentanyl.................................... 2
Betameprodine........................................... 2
Betamethadol............................................ 4
Betaprodine............................................. 2
Bufotenine.............................................. 3
Cathinone............................................... 70
Codeine methylbromide................................... 5
Codeine-N-oxide......................................... 200
Desomorphine............................................ 5
Diethyltryptamine....................................... 25
Difenoxin............................................... 50
Dihydromorphine......................................... 3,990,000
Dimethyltryptamine...................................... 35
Dipipanone.............................................. 5
Fenethylline............................................ 5
gamma-Hydroxybutyric acid............................... 70,250,000
Heroin.................................................. 25
Hydromorphinol.......................................... 2
Hydroxypethidine........................................ 2
Ibogaine................................................ 5
Lysergic acid diethylamide (LSD)........................ 35
Marihuana............................................... 21,000
Mescaline............................................... 25
Methaqualone............................................ 10
Methcathinone........................................... 25
Methyldesorphine........................................ 5
Methyldihydromorphine................................... 2
[[Page 37775]]
Morphine methylbromide.................................. 5
Morphine methylsulfonate................................ 5
Morphine-N-oxide........................................ 350
N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide 15
(AKB48)................................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- 15
indazole-3-carboxamide (ADB-PINACA)....................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)- 15
1H-indazole-3-carboxamide (AB-FUBINACA)................
N,N-Dimethylamphetamine................................. 25
Naphthylpyrovalerone (naphyrone)........................ 15
N-Benzylpiperazine...................................... 25
N-Ethyl-1-phenylcyclohexylamine......................... 5
N-Ethylamphetamine...................................... 24
N-Hydroxy-3,4-methylenedioxyamphetamine................. 24
Noracymethadol.......................................... 2
Norlevorphanol.......................................... 52
Normethadone............................................ 2
Normorphine............................................. 18
Phenomorphan............................................ 2
Psilocybin.............................................. 30
Psilocyn................................................ 30
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 15
(5-fluoro-PB-22; 5F-PB-22).............................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; 15
QUPIC).................................................
Tetrahydrocannabinols................................... 497,500
Thiofentanyl............................................ 2
Tilidine................................................ 10
Trimeperidine........................................... 2
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 5
1-Piperidinocyclohexanecarbonitrile..................... 5
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 2,687,500
Alfentanil.............................................. 17,625
Alphaprodine............................................ 3
Amobarbital............................................. 25,125
Amphetamine (for conversion)............................ 21,875,000
Amphetamine (for sale).................................. 37,500,000
Carfentanil............................................. 19
Cocaine................................................. 240,000
Codeine (for conversion)................................ 50,000,000
Codeine (for sale)...................................... 46,125,000
Dextropropoxyphene...................................... 19
Dihydrocodeine.......................................... 101,375
Diphenoxylate........................................... 1,337,500
Ecgonine................................................ 174,375
Ethylmorphine........................................... 3
Fentanyl................................................ 2,108,750
Glutethimide............................................ 3
Hydrocodone (for conversion)............................ 137,500
Hydrocodone (for sale).................................. 99,625,000
Hydromorphone........................................... 6,250,000
Isomethadone............................................ 5
levo-Alphacetylmethadol (LAAM).......................... 4
Levomethorphan.......................................... 5
Levorphanol............................................. 3,375
Lisdexamfetamine........................................ 29,750,000
Meperidine.............................................. 6,250,000
Meperidine Intermediate-A............................... 6
Meperidine Intermediate-B............................... 11
Meperidine Intermediate-C............................... 6
Metazocine.............................................. 19
Methadone (for sale).................................... 31,875,000
Methadone Intermediate.................................. 34,375,000
Methamphetamine......................................... 2,061,375
------------------------------------------------------------------------
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 750,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,375 grams for
methamphetamine (for sale)].
------------------------------------------------------------------------
Methylphenidate......................................... 83,750,000
Morphine (for conversion)............................... 91,250,000
Morphine (for sale)..................................... 62,500,000
Nabilone................................................ 18,750
Noroxymorphone (for conversion)......................... 17,500,000
[[Page 37776]]
Noroxymorphone (for sale)............................... 1,475,000
Opium (powder).......................................... 112,500
Opium (tincture)........................................ 687,500
Oripavine............................................... 22,750,000
Oxycodone (for conversion).............................. 8,350,000
Oxycodone (for sale).................................... 137,500,000
Oxymorphone (for conversion)............................ 21,875,000
Oxymorphone (for sale).................................. 7,750,000
Pentobarbital........................................... 35,000,000
Phenazocine............................................. 6
Phencyclidine........................................... 19
Phenmetrazine........................................... 3
Phenylacetone........................................... 9,375,000
Racemethorphan.......................................... 3
Remifentanil............................................ 3,750
Secobarbital............................................ 215,003
Sufentanil.............................................. 6,255
Tapentadol.............................................. 12,500,000
Thebaine................................................ 125,000,000
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 1,000,000
Ephedrine (for sale).................................... 3,000,000
Phenylpropanolamine (for conversion).................... 44,800,000
Phenylpropanolamine (for sale).......................... 8,500,000
Pseudoephedrine (for conversion)........................ 7,000
Pseudoephedrine (for sale).............................. 224,500,000
------------------------------------------------------------------------
The Deputy Administrator further proposes that aggregate production
quotas for all other schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 remain at zero. Pursuant to 21 CFR
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors,
the Deputy Administrator may adjust the 2015 aggregate production
quotas and assessment of annual needs as necessary.
Comments
In accordance with 21 CFR 1303.11(c) and 1315.11(d), any interested
person may submit written comments on or objections to these proposed
determinations. Based on comments received in response to this notice,
the Deputy Administrator may hold a public hearing on one or more
issues raised. 21 CFR 1303.11(c) and 1515.11(e). In the event the
Deputy Administrator decides to hold such a hearing, the Deputy
Administrator will publish a notice of the hearing in the Federal
Register. After consideration of any comments or objections, or after a
hearing, if one is held, the Deputy Administrator will issue and
publish in the Federal Register a final order establishing the 2015
aggregate production quota for each basic class of controlled substance
and establishing the assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 21 CFR
1303.11(c) and 1315.11(f).
Dated: June 26, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-15549 Filed 7-1-14; 8:45 am]
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